VEDA Study (DHEA vs Estradiol)

Официальное название

The Use of Vaginal Estrogen vs DHEA in Perimenopausal and Menopausal Women

Обзор

This study is being done to compare two vaginal treatments, vaginal estrogen and vaginal DHEA, that are used to treat vaginal and urinary symptoms related to menopause. These symptoms may include vaginal dryness, discomfort, painful intercourse, or urinary problems and can affect quality of life and sexual health. Women who choose to participate will be randomly assigned to use one of the two treatments for a set period of time. Participants will complete questionnaires about their symptoms and sexual health and have simple vaginal testing at the beginning and end of the study. The goal of this research is to better understand how these treatments affect vaginal health and sexual function so healthcare providers can make informed treatment decisions and improve care for postmenopausal women.

Подробное описание

This research study is being conducted to compare two commonly used vaginal therapies vaginal estrogen and vaginal DHEA for the treatment of vaginal and urinary symptoms that occur after menopause. Many postmenopausal women experience symptoms such as vaginal dryness, irritation, painful intercourse, decreased sexual comfort, or urinary symptoms including burning, urgency, or recurrent urinary discomfort. These symptoms, often related to decreased estrogen levels, can significantly affect daily activities, intimate relationships, and overall quality of life.

In this study, women who choose to participate will be randomly assigned (like the flip of a coin) to use either vaginal estrogen or vaginal DHEA for a defined treatment period. Randomization ensures that each participant has an equal chance of receiving either treatment, which helps researchers make fair and unbiased comparisons between the two options.

Participants will complete questionnaires at several time points throughout the study to report on their symptoms, sexual health, comfort, and overall satisfaction with treatment. At the beginning and end of the study, participants will also undergo simple vaginal assessments, which may include vaginal pH testing, collection of vaginal swabs, or other non-invasive measurements to evaluate changes in vaginal health over time.

The goal of this research is to gain a deeper understanding of how each treatment affects vaginal tissue health, sexual function, urinary symptoms, and overall well-being. By comparing these two therapies directly, the study aims to provide healthcare providers with clearer evidence about which treatment may be more effective for specific symptoms or patient needs. Ultimately, the findings may help improve clinical care and offer women more tailored, evidence-based options for managing postmenopausal vaginal and urinary symptoms.

Вмешательства

• Препарат DHEA ovals
  DHEA (dehydroepiandrosterone) is an inactive hormone precursor naturally produced by the body. When placed locally in the vagina, it is converted by vaginal cells into small amounts of estrogen and androgens exactly where the tissues need them. This helps restore the vaginal lining, improve moisture, and reduce pain.
• Препарат Estradiol 0.01% Vag Cream
  Estradiol 0.01% vaginal cream is a local (vaginal) estrogen therapy used to treat symptoms of genitourinary syndrome of menopause (GSM)-the thinning, dryness, and inflammation of vaginal and urinary tissues caused by postmenopausal estrogen decline.

Первичные конечные точки

• Genitourinary Symptoms [Срок оценки: Baseline/post treatment (6 month follow up)]

Вторичные конечные точки (1)

• Recurrent urinary tract infections [Срок оценки: Baseline/post treatment (6 month follow up)]

Критерии участия

Критерии включения

• Peri- or post-menopausal status
• Presence of any genitourinary or vaginal symptom (e.g., dryness, itching, discomfort, dyspareunia)
• Willingness and ability to use vaginal therapy
• Ability to provide informed consent
• English speaker
• Ages 40-90

Критерии исключения

• Use of systemic hormone therapy within the last 6 months
• Gynecologic malignancy
• Known allergy to study medications
• Active vaginal infection at enrollment
• Prior pelvic radiation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kaufman MR, Ackerman AL, Amin KA, Coffey M, Danan E, Faubion SS, Hardart A, Goldstein I, Ippolito GM, Northington GM, Powell CR, Rubin RS, Westney OL, Wilson TS, Lee UJ. The AUA/SUFU/AUGS Guideline on Genitourinary Syndrome of Menopause. J Urol. 2025 Sep;214(3):242-250. doi: 10.1097/JU.0000000000004589. Epub 2025 Apr 29. PMID 40298120
• Pieta W, Smolarczyk R. Vaginal dehydroepiandrosterone compared to other methods of treating vaginal and vulvar atrophy associated with menopause. Prz Menopauzalny. 2020 Dec;19(4):195-199. doi: 10.5114/pm.2020.101943. Epub 2021 Jan 7. PMID 33488333
• Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3. PMID 25511551
• Porcari I, Uccella S, Casprini C, Bosco M, Zorzato PC, Garzon S. Vulvovaginal estrogen therapy for urinary symptoms in postmenopausal women: a review and meta-analysis. Climacteric. 2026 Feb;29(1):13-22. doi: 10.1080/13697137.2025.2517138. Epub 2025 Jun 26. PMID 40569036
• Danan ER, Sowerby C, Ullman KE, Ensrud K, Forte ML, Zerzan N, Anthony M, Kalinowski C, Abdi HI, Friedman JK, Landsteiner A, Greer N, Nardos R, Fok C, Dahm P, Butler M, Wilt TJ, Diem S. Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review. Ann Intern Med. 2024 Oct;177(10):1400-1414. doi: 10.7326/ANNALS-24-00610. Epub 2024 Sep 10. PMID 39250810
• Simon JA, Goldstein I, Kim NN, Davis SR, Kellogg-Spadt S, Lowenstein L, Pinkerton JV, Stuenkel CA, Traish AM, Archer DF, Bachmann G, Goldstein AT, Nappi RE, Vignozzi L. The role of androgens in the treatment of genitourinary syndrome of menopause (GSM): International Society for the Study of Women's Sexual Health (ISSWSH) expert consensus panel review. Menopause. 2018 Jul;25(7):837-847. doi: 10.10 PMID 29870471
• Misasi G, Russo E, Montt Guevara MM, Tomatis V, Fidecicchi T, Luisi S, Giannini A, Mannella P, Caretto M, Pomara G, Simoncini T. Effects of vaginal DHEA on stress urinary incontinence in postmenopausal women with vulvovaginal atrophy. Maturitas. 2025 May;196:108232. doi: 10.1016/j.maturitas.2025.108232. Epub 2025 Mar 1. PMID 40068355
• Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. J Sex Med. 2014 Dec;11(12):2865-72. doi: 10.1111/jsm.12686. Epub 2014 Aug 25. PMID 25155380

Идентификаторы

NCT: NCT07574216 · STUDY00007779

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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